Current Environment:

Summary

The goals of this study are to 1) pilot the feasibility of a novel meal kit delivery intervention in families and children with food insecurity and obesity and 2) evaluate the implementation of the pilot intervention.

Conditions

Pediatric Obesity, Nutrition Disorders, Overnutrition, Child, Obesity

Recruitment Status

Completed

Detailed Description

Childhood obesity prevalence is rising in the U.S. and is known to track into adulthood, increasing the risks of chronic diseases such as type 2 diabetes. Households of children with obesity also face unmet social needs, such as food insecurity. Food insecurity is associated with poorer dietary quality and higher prevalence of obesity and diabetes in adults; however, data are inconsistent and less known regarding longitudinal health effects in children. Because food insecurity and childhood obesity tend to co-occur in Black, Hispanic, and lower-income households, there is an urgent need to examine and intervene in the social determinants associated with rising childhood obesity prevalence.

Eligibility Criteria

Inclusion Criteria:

Children >=6 years and <12 years old with a BMI >=95th percentile
Children who screen positive on the 2-item Hunger Vital Sign™
Children living in a household of <=5 people
Children living with an English and/or Spanish-speaking caregiver
Children living within the EatWell delivery map boundaries in the greater Boston area

Exclusion Criteria:

History of food allergies or intolerance to dairy, gluten, soy, or any potential component of the meal kit
History of malabsorptive intestinal disease (e.g., Crohn's disease, celiac disease)
History of type 1 or 2 diabetes
History of solid tumor or bone marrow transplant
Enteral tube dependence

Intervention

Intervention Type

Intervention Name

Behavioral

Meal Kit Delivery

Phase

Not Applicable

Gender

All

Min Age

6 Years

Max Age

12 Years

Download Date

November 8, 2023

Principal Investigator

Allison J Wu, MD, MPH

This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.

Primary Contact Information

Allison J Wu, MD, MPH
allison.wu@childrens.harvard.edu

This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team:

Intervening in Food Insecurity to Reduce and Mitigate (InFoRM) Childhood Obesity NCT05586269 Allison J Wu, MD, MPH allison.wu@childrens.harvard.edu